Clearance Summary
Biocore9 Femoral Head Resurfacing Component received FDA 510(k) clearance under submission number K201219, sponsored by Biocore9, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2021-01-19.
- Submission: K201219
- Applicant / Sponsor: Biocore9, LLC
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3400
- Decision date: 2021-01-19
Classification & Regulation
This clearance is catalogued under FDA product code KXA and 21 CFR 888.3400, within the Orthopedic review panel as a Class II device.